Condition category
Pregnancy and Childbirth
Date applied
29/06/2010
Date assigned
02/08/2010
Last edited
19/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://viis.abdn.ac.uk/hsru/Fest/

Contact information

Type

Scientific

Primary contact

Dr Pat Hoddinott

ORCID ID

Contact details

Senior Clinical Research Fellow and GP
Health Services Research Unit
University of Aberdeen
3rd Floor
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 558988
p.hoddinott@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2010PH001

Study information

Scientific title

Proactive telephone support for breastfeeding women in disadvantaged areas provided by a postnatal ward feeding support team: A nested, pilot, randomised controlled trial

Acronym

FEST (FEeding Support Team Study)

Study hypothesis

1. Is additional pro-active (health service initiated) telephone breastfeeding support offered to women living in disadvantaged areas after hospital discharge feasible and likely to be more effective than reactive telephone support at increasing the proportion of women who are breastfeeding exclusively at 6-8 weeks?
2. Is it feasible to have a dedicated feeding team, with skill mix, based on a postnatal ward to deliver feeding support to women on the ward and a telephone support service for up to 2 weeks to breastfeeding women after hospital discharge?
3. What are the opportunities and barriers to implementing the above two interventions?

Ethics approval

North of Scotland Research Ethics Committee approved on the 23rd of April 2010 (ref: 10/S0801/22)

Study design

Single centre pilot randomised controlled trial embedded within a mixed methods action research study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information sheet available at http://viis.abdn.ac.uk/hsru/Fest/

Condition

Breast feeding

Intervention

A multi-skilled feeding team will be set up to provide breastfeeding support on the postnatal ward and deliver a pilot RCT of pro-active/reactive telephone support after hospital discharge.

All trial participants:
Specialised feeding support team care on the postnatal ward including watching a breast feed. Ability for patients to telephone the feeding support team for up to 2 weeks after hospital discharge.
Intervention arm:
In addition, pro-active (feeding team initiated) daily telephone calls following hospital discharge for 1 week, with the option to continue for an extra week unless she chooses to withdraw from the study or stops breastfeeding before then.

RCT embedded within a before (3 months) and during the feeding support team intervention (3 months) audit of any breastfeeding (initiation and at 6-8 weeks after birth)

1. Steering group to oversee the project
1.1. Steering group of lay and professional representatives to meet every 4 weeks (recorded). Reflective action cycles. PH to chair.
1.2. Identify pregnant women due to deliver during the feeding team intervention and send information leaflets when they are 32-36 weeks pregnant
1.3. Map existing care pathways and resources for breastfeeding in Grampian to optimise the fit between the new feeding team and existing care.
1.4. Develop a triage system to assess need and provide other non-telephone support when required

2. Feeding team member characteristics
2.1. Feeding team members should
2.1.1. have personally breastfed
2.1.2. be trained and up to date in breastfeeding management ideally to UNICEF level
2.2. The team composition to be decided through the action research process. It might include midwives, nursery nurses, maternity aids, peer supporters.

3. Feeding team roles
3.1. To identify women initiating breastfeeding and living in eligible postcodes (list drawn up by the research team) and gain informed consent to participate
3.2. To watch a complete breastfeed for all women prior to hospital discharge and provide breastfeeding support on the ward for all consenting women
3.3. Document feeding method at discharge. If breastfeeding and they consent to the RCT they will be randomised immediately after hospital discharge
3.4. Immediately after hospital discharge, the feeding support team will access a web based independent randomisation system set up by CHART, a registered clinical trials unit at the University of Aberdeen, and they will be informed whether the woman is in the intervention (proactive daily phone calls) or control (no further intervention – women can phone the team) arm
3.5. All women randomised to the telephone support trial will be able to initiate phone calls to the feeding team for the first 2 weeks after hospital discharge
3.6. In the intervention arm, maximum support would be pro-active (feeding team initiated) daily telephone calls following hospital discharge for 1 week, with the option to continue for an extra week unless she chooses to withdraw from the study or stops breastfeeding before then
3.7. Triage to other care pathways if indicated, including a face to face assessment at a mutually convenient time and place e.g. assessment of positioning and attachment
3.8. Complete a telephone and patient contact time log
3.9. Attend steering group meetings

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Any breastfeeding at 6-8 weeks after birth

Secondary outcome measures

1. Exclusive breastfeeding at 6-8 weeks after birth
2. Satisfaction with hospital care
3. Satisfaction with care after discharge home
4. Process evaluation - qualitative interview data
5. Health Economic evaluation
All outcomes to be assessed at 6-8 weeks after birth using modifications of the tools used in the BIG trial (ISRCTN44857041; see http://www.controlled-trials.com/ISRCTN44857041)

Overall trial start date

26/07/2010

Overall trial end date

20/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Women living in the three most disadvantaged postcode area quintiles of the Scottish Index of Multiple Deprivation, who initiate breastfeeding while on a postnatal ward and consent to participate.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

1. Serious maternal medical or psychiatric problems
2. Serious infant health problems
3. Language problems that cannot be resolved through the use of language line

Recruitment start date

26/07/2010

Recruitment end date

20/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Senior Clinical Research Fellow and GP
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

c/o Dr E Rattray
Deputy Director
Research and Innovation
Aberdeen
AB24 3FX
United Kingdom
+44 (0)1224 277774
e.rattray@abdn.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NHS Grampian (UK) - Chief Executive Letter (CEL) 36: Nutrition of women of childbearing age, pregnant women and children under five in disadvantaged areas (funding allocation 2008 - 2011) (ref: 2010PH001)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22535790
2012 process evaluation results in: http://www.ncbi.nlm.nih.gov/pubmed/22535794

Publication citations

  1. Results

    Hoddinott P, Craig L, Maclennan G, Boyers D, Vale L, , The FEeding Support Team (FEST) randomised, controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas., BMJ Open, 2012, 2, 2, e000652, doi: 10.1136/bmjopen-2011-000652.

  2. Process evaluation results

    Hoddinott P, Craig L, Maclennan G, Boyers D, Vale L, , Process evaluation for the FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas., BMJ Open, 2012, 2, 2, e001039, doi: 10.1136/bmjopen-2012-001039.

Additional files

Editorial Notes